RightFit
RecruitingPhase 2

Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 64 weeks, 12 weeks, 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of anumigilimab (CSL324) in adults with sickle cell disease. It compares the drug, given as a shot under the skin, with a placebo (a treatment with no active drug). Treatment lasts 64 weeks, with doses raised during the first 12 weeks to find the highest dose each person can tolerate.

This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD. The primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older when signing the consent form.
  • Have a confirmed diagnosis of any type of sickle cell disease.
  • Had 1 to 12 sickle cell pain crises in the past 12 months that required a medical visit and opioid or anti-inflammatory pain medicine given by injection or through a vein.
  • Have taken a steady dose of hydroxyurea (HU) for at least 30 days before screening without major side effects, or have stopped or chosen not to take HU.

Who can't join

  • Have a neutrophil count below 2.5 billion cells per liter at screening or the first study visit. Neutrophils are white blood cells that fight infection.
  • Take medicine to prevent sickle cell problems, but its dose has not been steady for the 30 days before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults aged greater than or equal to (\>=) 18 years on the day of signing the informed consent form. * Confirmed diagnosis of SCD of any genotype. * Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening. * HU Regimen: * a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening. * or * b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect). Exclusion Criteria: * Absolute neutrophil count less than (\<) 2.5 ×10\^9 cells/Litre at Screening or Baseline (Week 1 Day 1). * If on SCD preventive medication, dose is not stable in the 30 days before Screening.

Study sites (9)

AR

CA

FL

GA

MD

MS

NY

OH

VA